Phase 3
Completed N=1,091
To Compare the Effect of Liraglutide When Given Together With Metformin With the Effect of Metformin Given Alone and With the Effect of Glimepiride and Metformin Given Together
Source: ClinicalTrials.gov NCT00318461 ↗Enrolled (actual)
1,091
Serious AEs
10.1%
Results posted
Mar 2010
Primary outcomePrimary: Change in Glycosylated A1c (HbA1c) at Week 26 — -0.69; -0.97; -1.00; 0.09 Percentage point of total HbA1c — p=<0.0001
Summary
This trial is conducted in Europe, Oceania, Africa, Asia and South America. This trial is designed to show the effect of treatment with liraglutide when adding to existing metformin therapy and to compare it with the effects of metformin monotherapy and combination therapy of metformin and glimepiride. Two trial periods: A 6 month (26 weeks) randomised, double-blinded period followed by an 18 months open-label extension, in total 2 years (104 weeks).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycosylated A1c (HbA1c) at Week 26 |
-0.69; -0.97; -1.00; 0.09; -0.98 | <0.0001 sig |
| PRIMARY Change in Glycosylated A1c (HbA1c) at Week 104 |
-0.36; -0.56; -0.58; 0.25; -0.50 | <0.0001 sig |
| SECONDARY Change in Body Weight at Week 26 |
-1.78; -2.58; -2.79; -1.51; 0.95 | 0.0016 sig |
| SECONDARY Change in Body Weight at Week 104 |
-2.07; -3.03; -2.91; -1.80; 0.70 | 0.0378 sig |
| SECONDARY Change in Fasting Plasma Glucose (FPG) at Week 26 |
-1.13; -1.63; -1.68; 0.40; -1.31 | <0.0001 sig |
| SECONDARY Change in Fasting Plasma Glucose (FPG) at Week 104 |
-0.80; -1.20; -1.18; 0.75; -0.64 | <0.0001 sig |
| SECONDARY Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26 |
-0.23; -0.40; -0.56; -0.44; -0.44 | 0.8871 |
| SECONDARY Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104 |
-0.27; -0.56; -0.44; -0.20; -0.29 | 0.5282 |
| SECONDARY Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26 |
-1.68; -2.33; -2.57; -0.62; -2.46 | <0.0001 sig |
| SECONDARY Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104 |
-1.59; -2.22; -2.10; -0.43; -1.80 | <0.0001 sig |
| SECONDARY Change in Beta-cell Function at Week 26 |
20.45; 20.33; 26.12; -1.63; 24.68 | 0.0031 sig |
| SECONDARY Change in Beta-cell Function at Week 104 |
64.48; 27.30; 17.81; -7.89; 11.25 | 0.8821 |
| SECONDARY Hypoglycaemic Episodes at Week 26 |
0; 0; 0; 0; 0; 15 | — |
| SECONDARY Hypoglycaemic Episodes at Week 104 |
52; 51; 49; 18; 524; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects diagnosed with type 2 diabetes and treated with oral anti-diabetic drugs (OADs) for at least 3 months
- HbA1c: 7.0-11.0 % (both incl.) in subjects on OAD monotherapy. 7.0-10.0 % (both incl.) in subjects on OAD combination therapy
- Body Mass Index (BMI) less than or equal 40 kg/m2
Exclusion Criteria
- Subjects treated with insulin within the last three months
- Subjects with any serious medical condition
- Females of child bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods
- Subjects using any drug (except for OADs), which in the Investigator's opinion could interfere with the glucose level (e.g. systemic corticosteroids)
Data sourced from ClinicalTrials.gov (NCT00318461). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.